Assessing Adult Patients with Facial Deformities for Injectable Treatment: Do Current Classification Systems and Methodologies Meet Important Patient Needs?

BACKGROUND: Many individuals are affected by facial deformities. Injectable aesthetic treatments can often be used to improve appearance and/or dynamic function. However, to best meet the needs of these patients, broadly applicable methodologies are required for classifying the deformity, assessing severity, and developing a treatment strategy. OBJECTIVE: To assess whether any published systems could be used for this purpose. METHODS: Thirty-eight searches were conducted in PubMed (1999-2019; in English). Forty-two publications were identified describing novel classification systems for adult facial deformity. They were analyzed against a checklist of 10 characteristics defining an "optimal" system-based on appropriate anatomical coverage, wide usability across types of deformity, user-friendliness, applicable underlying methodology, and ability to guide treatment with injectables. RESULTS: None of the systems met more than 7 of the 10 checklist criteria; none were usable across multiple types of deformity or provided a recommendation for treatment with injectables. CONCLUSION: There remains a need for a broadly applicable system for classifying adult facial deformities ahead of injectable therapy. The checklist provides a developmental framework. With the increasing popularity and accessibility of injectables, this diverse and complex demographic is at risk of mismanagement without superior methods for devising treatment strategies.

Facial Aesthetic Priorities and Concerns: A Physician and Patient Perception Global Survey.

BACKGROUND: Minimally invasive and noninvasive facial aesthetic treatments are increasingly popular, and a greater understanding of patient perspectives on facial aesthetic priorities is needed. OBJECTIVES: The authors surveyed facial aesthetic concerns, desires, and treatment goals of aesthetically conscious men and women, and physicians, in 18 countries. METHODS: This was a global, internet-based survey on desired appearance and experiences with, or interest in, facial aesthetic treatments. Eligible respondents were aesthetically conscious adults (21-75 years). Eligible aesthetic physicians were required to see ≥30 patients per month for aesthetic reasons, have 2 to 30 years of experience in clinical practice, and spend ≥70% of their time in direct patient care. RESULTS: A total of 14,584 aesthetically conscious adults (mean age, 41 years; 70% women) and 1315 aesthetic physicians (mean age, 45 years; 68% men) completed the survey. Most respondents (68%) reported that aesthetic procedures should be sought in their 30s to 40s; physicians recommended patients seek treatment earlier. Respondents expressed greatest concern over crow's feet lines, forehead lines, facial skin issues, hair-related concerns, and under-eye bags or dark circles; in contrast, physicians tended to underestimate concerns about under-eye bags or dark circles, mid-face volume deficits, and skin quality. Although both physicians and respondents cited cost as a major barrier to seeking aesthetic treatments, respondents also emphasized safety, fear of injections or procedure-related pain, and concern about unnatural-looking outcomes. CONCLUSIONS: This global survey provides valuable insight into facial aesthetic concerns and perspectives that may be implemented in patient education and consultations to improve patient satisfaction following aesthetic treatments.

Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study.

BACKGROUND: Juvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement. OBJECTIVE: Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®). METHODS: This study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan's Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥ 1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment. RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P ≤ .03), perioral lines (P ≤ .04), and oral commissures (P ≤ .03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler. CONCLUSIONS: Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.

Enhanced patient retention after combination vs single modality treatment using hyaluronic acid filler and neuromodulator: A multicenter, retrospective review by The Flame Group.

BACKGROUND: It is believed that combination treatment with both neuromodulators (NM) and hyaluronic acid soft-tissue fillers (HA) results in superior aesthetic results and increased patient satisfaction compared to either treatment alone. AIMS: To determine whether combined treatment with NM and HA leads to greater patient retention than treatment with NM or HA alone. PATIENTS/METHODS: This is a large, multi-center, retrospective review of patient retention rates from 7 aesthetic practices across 5 continents, incorporating over 2600 patients. Patient retention is interpreted as a surrogate marker for overall patient satisfaction. Retention rates were compared at 1, 3, and 5 years for patients who received NM only, HA only, or combination treatment with both NM and HA. RESULTS: Combination therapy significantly increased the probability of retention for each time point (1, 3, and 5 years) compared with NM alone (P < .0001) and HA alone (P < .0001). CONCLUSION: This large multicenter, global retrospective review demonstrates that patients who received combined HA and NM were more likely to be retained in the same practice over many years than those who received either treatment alone.

Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies.

BACKGROUND: Research into mechanisms of skin scarring identified transforming growth factor beta3 (TGFbeta3) as a potential antiscarring therapy. We assessed scar improvement with avotermin (recombinant, active, human TGFbeta3). METHODS: In three double-blind, placebo-controlled studies, intradermal avotermin (concentrations ranging from 0.25 to 500 ng/100 microL per linear cm wound margin) was administered to both margins of 1 cm, full-thickness skin incisions, before wounding and 24 h later, in healthy men and women. Treatments (avotermin and placebo or standard wound care) were randomly allocated to wound sites by a computer generated randomisation scheme, and within-participant controls compared avotermin versus placebo or standard wound care alone. Primary endpoints were visual assessment of scar formation at 6 months and 12 months after wounding in two studies, and from week 6 to month 7 after wounding in the third. Investigators, participants, and scar assessors were blinded to treatment. Efficacy analyses were intention to treat. These studies are registered with ClinicalTrials.gov, numbers NCT00847925, NCT00847795, and NCT00629811. RESULTS: In two studies, avotermin 50 ng/100 microL per linear cm significantly improved median score on a 100 mm visual analogue scale (VAS) by 5 mm (range -2 to 14; p=0.001) at month 6 and 8 mm (-29 to 18; p=0.0230) at month 12. In the third, avotermin significantly improved total scar scores at all concentrations versus placebo (mean improvement: from 14.84 mm [95 % CI 5.5-24.2] at 5 ng/100 microL per linear cm to 64.25 mm [49.4-79.1] at 500 ng/100 microL per linear cm). Nine [60%] scars treated with avotermin 50 ng/100 microL per linear cm showed 25% or less abnormal orientation of collagen fibres in the reticular dermis versus five [33%] placebo scars. After only 6 weeks from wounding, avotermin 500 ng/100 microL per linear cm improved VAS score by 16.12 mm (95% CI 10.61-21.63). Adverse events at wound sites were similar for avotermin and controls. Erythema and oedema were more frequent with avotermin than with placebo, but were transient and deemed to be consistent with normal wound healing. INTERPRETATION: Avotermin has potential to provide an accelerated and permanent improvement in scarring.

Understanding and treating different patient archetypes in aesthetic medicine.

BACKGROUND: Factors that motivate the treatment goals and expectations of the aesthetic patient reflect evolving social, cultural, and commercial influences. The aesthetic practitioner may often be faced with the challenge of first decoding the underlying motives that drive the patient to pursue their specific goals. The challenge for clinicians is further compounded by an increase in patient diversity with respect to race, ethnicity, age, and gender. AIMS: Simplify the path to patient interpretation with identification of primary patient archetypes. METHODS: The "Going Beyond Beauty" (GBB) initiative, consisting of 27 market research projects, was conducted to survey the primary goals and motives for seeking treatment aesthetic treatment. The results were stratified into predominant patient archetypes using segmentation analysis and then validated through online surveys, 1-to-1 interviews, and focus groups conducted with patients. An advisory board of internationally based aesthetic clinicians integrated the data with their own insights to further characterize each archetype. RESULTS: Data from over 54 000 participants in 17 different countries were distilled into four distinct patient archetypes based on motivating factors, aesthetic goals, initial treatment requests, and treatment opportunities and challenges. These archetypes were named Beautification, Positive Aging, Transformation, and Correction. CONCLUSION: The clinician's ability to recognize these four primary archetypes may provide a useful frame of reference to understand patient motives better, anticipate and manage their expectations, and provide the appropriate treatment guidance that best serves the long-term goals of their patients.

Improvements in satisfaction with skin after treatment of facial fine lines with VYC-12 injectable gel: Patient-reported outcomes from a prospective study.

BACKGROUND: VYC-12, a hyaluronic acid injectable gel, is designed to treat fine lines and provides improvements in other skin quality attributes. A prospective study demonstrated the safety and effectiveness of VYC-12 for the improvement of fine lines as measured by changes in skin texture. AIMS: To evaluate patient-reported outcomes in subjects treated intradermally with VYC-12 in the cheeks, forehead, and neck (optional) in the prospective study. METHODS: Subjects received an initial treatment of VYC-12 (N = 131), with a touch-up treatment, if deemed necessary, offered 30 days later, and optional repeat treatment 9 months after initial or touch-up treatment. Subjects completed the FACE-Q Satisfaction With Skin scale and assessed willingness to recommend treatment to a friend at baseline, months 1, 4, 6, and 9, and month 1 after repeat treatment. Subjects also evaluated their return to normal daily social activities. RESULTS: Satisfaction with skin improved from baseline in 90.8% of subjects at month 1, 88.4% at month 4, 83.6% at month 6, 76.4% at month 9, and 91.9% at month 1 after repeat treatment (P < .001, all time points). At least 94% of subjects returned to normal daily social activities one day after treatment (initial, touch-up, or repeat). More than 80% of subjects said they would recommend treatment to a friend at all time points through month 9 (97% at month 1 after repeat treatment). CONCLUSION: Treatment with VYC-12 significantly improved satisfaction with skin in the majority of subjects, with most subjects returning to normal activities 1 day after treatment.

Expert Consensus on Injection Technique and Area-Specific Recommendations for the Hyaluronic Acid Dermal Filler VYC-12L to Treat Fine Cutaneous Lines.

BACKGROUND: VYC-12L is a hyaluronic acid (HA) injectable gel designed to treat fine cutaneous lines and improve skin quality attributes such as hydration and elasticity. OBJECTIVE: Expert consensus was sought on VYC-12L injection technique and primary treatment target areas. METHODS: A multinational group of aesthetic medicine clinicians (n = 128) attended product training and each identified ~10 patients for VYC-12L. After treating their first and last patients, the clinicians completed a survey on preferred injection methodology/technique, including injection angle, volume, and spacing. An expert panel (n = 12) discussed survey results and their clinical experiences to obtain consensus on VYC-12L technique and appropriate treatment areas. RESULTS: Recommendations included micro-depot injections of VYC-12L into the deep dermis with a 32G ½ inch needle inserted at <45º to the skin, spaced 0.5‒1.0 cm apart, with 0.01‒0.05 mL volume per injection (full-face total volume: ~2 mL). Recommended primary treatment areas were the malar, perioral, neck, and décolletage regions. Injection techniques for different treatment areas/demographic characteristics were similar, with some variability in treatment approach. Patient selection criteria, pre- and post-treatment guidelines, and managing patient expectations are important components of treatment. CONCLUSION: These consensus recommendations may assist clinicians in optimizing the treatment of fine lines with VYC-12L.

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

OBJECTIVE: Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection. MATERIALS AND METHODS: In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ≥1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed. RESULTS: Of 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate. CONCLUSION: VYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.

Juvéderm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial.

BACKGROUND: Juvéderm Volbella with Lidocaine is a new hyaluronic acid dermal filler. METHODS: In this prospective, randomized, multicenter study, 280 subjects desiring lip volume enhancement were treated with Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated treatment outcomes on Allergan's Lip Fullness Scale, Perioral Lines Scale, and Oral Commissures Severity Scale. A blinded independent central reviewer (ICR) assessed 3-dimensional digital photographs using these scales. Subjects evaluated outcomes using the FACE-Q Recovery Early Life Impact and Recovery Early Symptoms modules. The primary endpoint was noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L based on responder rate (percentage of subjects with ≥1-point Lip Fullness Scale improvement at month 3 ICR assessment vs baseline). RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L. Although responder rates based on ICR assessments of lip fullness, perioral lines, and oral commissures did not differ between treatments, investigator assessments showed significant improvements in perioral lines and oral commissures with Juvéderm Volbella with Lidocaine vs Restylane-L (P ≤ 0.029). Subjects treated with Juvéderm Volbella with Lidocaine had higher mean FACE-Q scores on day 1 (P ≤ 0.001), indicating less disruption of daily activities. Mean change in lip volume from baseline to day 1 was smaller in the Juvéderm Volbella with Lidocaine group (but similar between treatments on day 14), indicating less acute swelling. Severe injection site responses occurred less frequently with Juvéderm Volbella with Lidocaine. CONCLUSIONS: Juvéderm Volbella with Lidocaine is effective for lip enhancement, improves perioral lines and oral commissures, and results in less short-term swelling and disruption in daily activities than Restylane-L.

Predictors of 5 year survival following hip fracture.

BACKGROUND: This study aims to assess the mortality associated with hip fracture at 5 years in a geriatric population, and evaluate the influence of age, cognitive state, mobility and residential status on long term survival after hip fracture. METHODS: A prospective audit was carried out of all patients with a hip fracture admitted to a university hospital over a 4 year period. Data from 2640 patients were analysed and multivariate analysis used to indicate the important variables predicting mortality. Patients fulfilling the criteria of age<80 years, Abbreviated Mental Test Score (AMT)≥7/10, independently mobile and admitted from own home were put into group A (low risk group). Patients not meeting the criteria were placed into group B (high risk group). RESULTS: 2640 patients fitted the inclusion criteria, 482 in group A and 2158 in group B. 850 patients (43.1%) died in their first year following hip fracture. 302 patients (63%) of group A were still alive at 5 years in comparison with only 367 (17%) of group B. Overall, 669 (25%) patients survived for 5 years. Increased survival was shown for the following variables: age<80 years RR 5.27 (p<0.01), AMT≥7/10 RR 6.03 (p<0.01), independent mobility RR 2.63 (p<0.01) and admitted from own home RR 4.52 (p<0.01). CONCLUSIONS: These findings will allow for early recognition of those patients with an increased chance of long-term survival following hip fracture. Such patients may be suitable for surgical treatment, such as total hip replacement, which has a good long-term outcome.

Remote wound monitoring of chronic ulcers.

Chronic wounds or ulcers are wounds that do not heal in the usual manner. This type of wound is most common in the elderly and in paraplegic patients with an estimated 1% of the population suffering from leg ulcers and the costs adding up to 4% of the annual National Health Service budget in the U.K. There is an identified need to develop a device capable of remote wound monitoring that enables patients to take charge of their wound management under clinical guidance. A new ¿wound mapping¿ device has been developed, which is based on electrical impedance spectroscopy and involves the multifrequency characterization of the electrical properties of wound tissue under an electrode array. A key feature of the prototype device is the anticipated incorporation of the measuring array into standard commercial occlusive dressings, thereby protecting the wound from interference and contamination, and thus, promoting wound healing, while monitoring the protected wound. Further development is planned including wireless transmission, thus enabling telewound monitoring as described earlier.